Inflatable bone tamp with flow control and methods of use

ABSTRACT

An inflatable bone tamp is provided that includes a shaft with proximal and distal portions and a central longitudinal axis. A balloon is attached to the shaft such that a material can flow through the shaft and into the balloon to inflate the balloon. A flow controller controls the flow of the material through the shaft and into the balloon. Kits, systems and methods are disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.15/138,670, filed Apr. 26, 2016, all of which is incorporated byreference herein.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of bone disorders, and more particularly to devices andmethods for treating spinal disorders, such as, for example, vertebralcompression fractures.

BACKGROUND

Height loss is commonly associated with spinal fractures, such as, forexample, vertebral compression fractures. Spinal fractures affect alarge segment of osteoporotic patients. It is estimated thatapproximately 700,000 spinal fractures occur annually from osteoporosis,for example. Procedures have been developed to treat spinal fractures.One such procedure is kyphoplasty. Kyphoplasty is a minimally invasiveprocedure that is used to treat spinal fractures, such as, for example,vertebral compression fractures by inserting one or more balloons, suchas, for example, compliant balloons inside a fractured vertebral body.The balloon or balloons are inflated within the fractured vertebral bodysuch that the cancellous bone of the vertebral body is pushed towardscortical walls of the vertebral body to form a cavity within thevertebral body. The cavity is then at least partially filled with amaterial, such as, for example, bone cement.

However, conventional spinal fracture treatment procedures lack a meansto control the inflation rate of the balloon or balloons. This may leadto uneven inflation, balloon ruptures, or suboptimal balloonperformance. To achieve optimal results, there is a need to provide aballoon or balloons that are inflated slowly to allow the balloon orballoons to gradually compress bone and restore height to the vertebralbody. Bone is a viscoplastic material that needs time to deform. Fastinflation does not allow the balloon to create a large cavity.Conventional spinal fracture treatment procedures rely on the physicianto control the inflation rate of the balloon or balloons. Thisdisclosure describes an improvement over these prior art technologies.Inflating at a lower rate is not typically desired because it leads to alonger procedure time. However, providing a more steady and uniforminflation rate as described herein will lead to better and morepredictable patient outcomes.

SUMMARY

New devices and methods are provided for the treatment of bonedisorders, and more particularly devices and methods for treating spinaldisorders, such as, for example, vertebral compression fractures. Insome embodiments, the devices comprise an inflatable bone tamp (IBT)comprising a shaft. A balloon is coupled to the shaft such that amaterial can flow through the shaft and into the balloon to inflate theballoon. The IBT comprises a flow control device that controls the flowof the material through the shaft and into the balloon.

In some embodiments, the flow control device comprises a flowcontroller. In some embodiments, the flow control device comprises aplurality of flow controllers. In some embodiments, the IBT comprises aconnector that is coupled to the shaft. In some embodiments, theconnector is a V-connector. In some embodiments, the flow controller iscoupled to the connector. In some embodiments, the flow controller ismounted in the connector.

In some embodiments, the IBT comprises a shaft having a proximalportion, a distal portion, and a central longitudinal axis. In someembodiments, there is an outer shaft and an inner shaft positionedwithin the outer shaft. The balloon can be coupled to the distal portionof the shaft such that a material can flow through the shaft and intothe balloon to inflate the balloon. In some embodiments the balloon canbe coupled to the inner shaft and/or the outer shaft. In someembodiments, the flow controller is positioned between the outer shaftand the inner shaft. The flow controller can be coupled to the shaftbetween the proximal portion and the distal portion that controls theflow of the material through the shaft and into the balloon. In someembodiments, the flow controllers are mounted in the space between theinner shaft and the outer shaft. In some embodiments, the flowcontroller is coupled to the outer shaft. In some embodiments, the flowcontroller is mounted in the outer shaft. In some embodiments, the flowcontroller is coupled to the inner shaft. In some embodiments, the flowcontroller is mounted in the inner shaft. In some embodiments, the flowcontroller is crimped onto the inner shaft. In some embodiments, theflow controller is crimped onto the outer shaft. In some embodiments,the flow controller is crimped onto the outer shaft and comprises aplurality of flow controllers that act as flow chokes. There areembodiments where the flow controller comprises a spongiform structure.

Additional features and advantages of various embodiments will be setforth in part in the description that follows, and in part will beapparent from the description, or may be learned by practice of variousembodiments. The objectives and other advantages of various embodimentswill be realized and attained by means of the elements and combinationsparticularly pointed out in the description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 1A is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 1;

FIG. 1B is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 1A;

FIG. 2 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 1;

FIG. 3 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 1;

FIG. 4 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 1;

FIG. 5 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 1;

FIG. 6 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 7 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 6:

FIG. 8 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 9 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 8;

FIG. 10 is a breakaway, side, cross sectional view of a portion of oneembodiment of the surgical instruments shown in FIGS. 1, 6 and 8;

FIG. 11 is a breakaway, side, cross sectional view of components of oneembodiment of the surgical instruments shown in FIGS. 1, 6 and 8;

FIG. 12 is breakaway, a side, cross sectional view of the componentsshown in FIG. 11;

FIG. 13 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 13A is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 1;

FIG. 13B is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 13A;

FIG. 14 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 13;

FIG. 15 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 13;

FIG. 16 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 15;

FIG. 17 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 15;

FIG. 18 is a breakaway, side, cross sectional view of a portion of oneembodiment of the surgical instrument shown in FIGS. 13 and 13A;

FIG. 19 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 20A is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 19;

FIG. 20B is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 19;

FIG. 21 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 22 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 21;

FIG. 23 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 21;

FIG. 24 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 23;

FIG. 25 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 23;

FIG. 26 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 27 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 26;

FIG. 28 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 26;

FIG. 29 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 26;

FIG. 30 is a breakaway, side, cross sectional view of one embodiment ofthe surgical instrument shown in FIG. 26;

FIG. 31 is a breakaway, side, cross sectional view of a surgicalinstrument in accordance with the principles of the present disclosure;

FIG. 32 is a cross sectional view of one embodiment of the surgicalinstrument shown in FIG. 31;

FIG. 33 is a breakaway, side, cross sectional view of a portion of oneembodiment of the surgical instruments shown in FIGS. 19, 21, 26 and 31;

FIG. 34 is a breakaway, side, cross sectional view of a portion of oneembodiment of the surgical instruments shown in FIGS. 19, 21 26 and 31;

FIG. 35 is a cross sectional view of one embodiment of the portion ofone embodiment of components of the surgical instruments shown in FIGS.19, 21, 26 and 31; and

FIG. 36 is a cross sectional view of one embodiment of the portion ofone embodiment of components of the surgical instruments shown in FIGS.19, 21, 26 and 31.

DETAILED DESCRIPTION

For the purposes of this specification and appended claims, unlessotherwise indicated, all numbers expressing quantities of ingredients,percentages or proportions of materials, and other numerical values usedin the specification and claims, are to be understood as being modifiedin all instances by the term “about.” Accordingly, unless indicated tothe contrary, the numerical parameters set forth in the followingspecification and attached claims are approximations that may varydepending upon the desired properties sought to be obtained by thepresent invention. At the very least, and not as an attempt to limit theapplication of the doctrine of equivalents to the scope of the claims,each numerical parameter should at least be construed in light of thenumber of reported significant digits and by applying ordinary roundingtechniques.

Notwithstanding the numerical ranges and parameters set forth herein,the broad scope of the invention are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements. Moreover, all ranges disclosed hereinare to be understood to encompass any and all subranges subsumedtherein. For example, a range of “1 to 10” comprises any and allsubranges between (and including) the minimum value of 1 and the maximumvalue of 10, that is, any and all subranges having a minimum value ofequal to or greater than 1 and a maximum value of equal to or less than10, e.g., 5.5 to 10.

Reference will now be made in detail to certain embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in conjunction with theillustrated embodiments, it will be understood that they are notintended to limit the invention to those embodiments. On the contrary,the invention is intended to cover all alternatives, modifications, andequivalents that may be comprised within the invention as defined by theappended claims.

This disclosure is directed to an inflatable bone tamp, such as, forexample, a balloon catheter 40. In some embodiments, the components ofballoon catheter 40 can be fabricated from biologically acceptablematerials suitable for medical applications, including metals, syntheticpolymers, ceramics and bone material and/or their composites, dependingon the particular application and/or preference of a medicalpractitioner. For example, the components of balloon catheter 40,individually or collectively, can be fabricated from materials such asstainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (e.g., Nitinol,super elasto-plastic metals, such as GUM METAL® manufactured by ToyotaMaterial Incorporated of Japan), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe andtheir combinations.

Various components of balloon catheter 40 may have material composites,including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of balloon catheter 40, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of balloon catheter 40 may be monolithically formed,integrally connected or comprise fastening elements and/or instruments,as described herein.

Balloon catheter 40 comprises an outer shaft or cylindrical portion 42and a balloon 44 coupled to cylindrical portion 42. In the embodimentsshown in FIGS. 1-5, a proximal portion 44 a of balloon 44 is coupled tocylindrical portion 42 and an opposite distal portion 44 b of balloon 44is spaced apart from or nonadjacent to the cylindrical portion 42.Cylindrical portion 42 is hollow and defines a passageway 46. In someembodiments, passageway 46 is in communication with an internal chamber48 of balloon 44. In some embodiments, passageway 46 is configured tofor passage of a material to move balloon 44 from an unexpandedconfiguration, such as, for example, an uninflated configuration to anexpanded configuration, such as, for example, an inflated configuration.That is, a material may be moved through passageway 46 and into chamber48 to move balloon 44 from the uninflated configuration to the inflatedconfiguration. VVhen balloon 44 is in the inflated configuration,balloon 44 has a maximum diameter that is greater than the maximumdiameter of balloon 44 when balloon 44 is in the uninflatedconfiguration. In some embodiments, the material is a liquid, such as,for example, a contrast solution, saline or water. In some embodiments,passageway 46 is configured for passage of a material to move balloon 44from the inflated configuration to the uninflated configuration, asdiscussed herein. That is, the material moves through passageway 46 toallow balloon 44 to deflate.

In some embodiments, cylindrical portion 42 is a hollow shaft or tube.In some embodiments, cylindrical portion 42 is flexible to allowcylindrical portion 42 to bend as cylindrical portion 42 is navigatedthrough a patient's anatomy. For example, cylindrical portion 42 may beflexible to allow cylindrical portion 42 to be navigated along a curvedpath created by a medical practitioner in order to position balloon 44at, in or near a target location or treatment zone, such as, forexample, within a vertebral body. In embodiments wherein cylindricalportion 42 is flexible, cylindrical portion 42 can be bent withoutbreaking cylindrical portion 42. In some embodiments, cylindricalportion 42 is rigid such that cylindrical portion 42 cannot be bentwithout cylindrical portion 42 breaking. For example, cylindricalportion 42 may be rigid to provide strength to cylindrical portion 42 inapplications wherein balloon catheter 40 is navigated along a straightpath created by a medical practitioner in order to position balloon 44at, in or near a target location or treatment zone, such as, forexample, a space within a vertebral body.

In some embodiments, balloon 44 is made from a resilient biocompatiblematerial. In one embodiment, balloon 44 is a compliant balloon thatresists stretching. In one embodiment, balloon 44 comprises polyolefincopolymer (POC), Polyurethane, Nylon. In one embodiment, balloon 44 is anon-compliant or semi-compliant balloon that stretches, at least to somedegree. In one embodiment, balloon 44 comprises polyethyleneterapthelate (PET). In some embodiments, balloon 44 can have variouscross section configurations when balloon 44 is in the inflatedconfiguration, such as, for example, oval, oblong, triangular,rectangular, square, polygonal, irregular, uniform, non-uniform,variable, tubular and/or tapered. In some embodiments, an outer surfaceof balloon 44 may have various surface configurations, such as, forexample, smooth and/or surface configurations to enhance fixation withtissue, such as, for example, rough, arcuate, undulating, porous,semi-porous, dimpled, polished and/or textured.

Balloon 44 can be a single or a multi-layered balloon, where eachballoon layer has the same diameter and/or wall thickness, is comprisedof the same material or materials having substantially identicalmechanical properties, and has the same degree of molecular orientationin the body portion of the balloon. It will be apparent that in somesituations it will be desirable to have some balloon layers havingdifferent thicknesses, materials, and/or degree of molecularorientations upon deflation, while at the same time having equivalentsize, mechanical properties, and/or orientation upon inflation.

Balloon catheter 40 comprises one or a plurality of flow controllers 50.In the embodiments shown in FIGS. 1-5, flow controllers 50 arepositioned within cylindrical portion 42. In these embodiments, flowcontrollers 50 are configured to control the flow of the materialthrough passageway 46 as the material travels through passageway 46. Insome embodiments, flow controllers 50 directly engage an inner surface52 of cylindrical portion 42 such that a central portion of passageway46 is unobstructed along a central longitudinal axis CLA defined bycylindrical portion 42, as shown in FIGS. 1, 2 and 3. In someembodiments, flow controllers 50 directly engage inner surface 52 ofcylindrical portion 42 such that at least one of flow controllers 50block and/or obstruct the central portion of passageway 46 along centrallongitudinal axis CLA, as shown in FIGS. 1A and 1B.

In some embodiments, flow controllers 50 comprise a material, such as,for example, one of the materials discussed herein. In some embodiments,flow controllers 50 comprise a non-porous material. Flow controller 50may be comprised a discrete bands concentric to central longitudinalaxis CLA or discrete strips that extend parallel to central longitudinalaxis CLA, as shown in FIGS. 1-3. In some embodiments, flow controllers50 comprise a porous material that may be a lattice-like or spongiformstructure. In some embodiments, flow controllers 50 comprise a foammaterial, such as, for example, an open cell foam material or spongiformmaterial/structure. In some embodiments, the open cell foam material orspongiform material/structure comprises one or a plurality of pores 54,as shown in FIG. 1B. In some embodiments, at least one of pores 54extends through opposite proximal and distal surfaces 50 a, 50 b arespective flow controller 50. In some embodiments, at least one ofpores 54 extends through one of proximal and distal surfaces 50 a, 50 bwithout extending through the other one of proximal and distal surfaces50 a, 50 b. In some embodiments, at least one of pores 54 is incommunication with at least another one of pores 54. In someembodiments, pores 54 are interconnected with one another. In someembodiments, pores 54 are nonadjacent to one another and/or are not incommunication with one another.

In some embodiments, balloon catheter 40 comprises one or a plurality offlow controllers 50 that extend continuously from a proximal portion 42a of cylindrical portion 42 to an opposite distal portion 42 b ofcylindrical portion 42. That is, one or more of flow controllers 50 mayhave a maximum length along central longitudinal axis CLA that is equalto a maximum length of cylindrical portion 42 along central longitudinalaxis CLA. In some embodiments, balloon catheter 40 comprises a singleflow controller 50 that that extends continuously from proximal portion42 a to distal portion 42 b and also extends 360 degrees about centrallongitudinal axis CLA, as shown in FIG. 2, for example. In someembodiments, balloon catheter 40 comprises a plurality of flowcontrollers 50 that extends continuously from proximal portion 42 a todistal portion 42 b and are nonadjacent to one another or spaced apartabout a circumference of cylindrical portion 42, as shown in FIG. 3.Flow Controllers 50 can be comprised of discrete strips coupled alongthe shaft parallel to the central longitudinal axis. Flow controllers 50each can have a height defined between opposite first and secondsurfaces 50 c, 50 d. The flow controllers can be comprised of discretebands that are concentric to central longitudinal axis CLA, as shown inFIG. 1. In some embodiments, the flow controller can be discrete stripscoupled along the shaft that extend continuously from proximal portion42 a to distal portion 42 b with a uniform height from proximal portion42 a to distal portion 42 b. In some embodiments, the flow controller 50can be discrete strips that extend continuously from proximal portion 42a to distal portion 42 b taper from proximal portion 42 a to distalportion 42 b. In some embodiments, the flow controller(s) 50 thatextend(s) continuously from proximal portion 42 a to distal portion 42 btaper from distal portion 42 b to proximal portion 42 a.

In some embodiments, balloon catheter 40 comprises a plurality of flowcontrollers 50 that are nonadjacent to one another or spaced apart alongcentral longitudinal axis CLA, as shown in FIG. 1. In some embodiments,flow controllers 50 are discrete bands concentric to centrallongitudinal axis CLA. In some embodiments, the spaced apart flowcontrollers 50 are uniformly nonadjacent to one another or spaced apartalong central longitudinal axis CLA. In some embodiments, at least oneof the spaced apart flow controllers 50 extends 360 degrees aboutcentral longitudinal axis CLA, as shown in FIG. 2, for example. In suchembodiments, flow controllers 50 are discrete bands concentric tocentral longitudinal axis CLA. In some embodiments, the spaced apartflow controllers 50 are nonadjacent to one another or spaced apart alongcentral longitudinal axis CLA, as shown in FIG. 1 and are alsononadjacent to one another or spaced apart about a circumference ofcylindrical portion 42, as shown in FIG. 3. In such embodiments, flowcontrollers 50 are discrete strips that extend parallel to centrallongitudinal axis CLA.

In the embodiments shown in FIGS. 1-5, first surfaces 50 c of the spacedapart flow controllers 50 engage inner surface 52 of cylindrical portion42. In some embodiments, the spaced apart or discrete flow controllers50 are each tapered from proximal portion 50 a to distal portion 50 b.In some embodiments, the discrete flow controllers 50 are each taperedfrom distal portion 50 b to proximal portion 50 a. In some embodiments,each of the discrete flow controllers 50 have the same height, as shownin FIG. 1. In some embodiments, each of the spaced apart flowcontrollers 50 have a different height, wherein the flow controller 50having the greatest height is positioned at proximal portion 42 a ofcylindrical portion 42 and the flow controller having the least heightis positioned at distal portion 42 b of cylindrical portion 42, as shownin FIG. 4. In some embodiments, each of the spaced apart flowcontrollers 50 have a different height, wherein the flow controller 50having the greatest height is positioned at distal portion 42 b ofcylindrical portion 42 and the flow controller 50 having the leastheight is positioned at proximal portion 42 a of cylindrical portion 42,as shown in FIG. 5. The height(s) of the flow controller(s) 50 betweenthe flow controllers 50 with the greatest and least heights is less thanthe height of the flow controller 50 with the greatest height andgreater than the flow controller 50 with the least height such that flowcontrollers 50 have a stepped configuration, as shown in FIGS. 4 and 5.

In use, to treat a bone disorder, such as, for example, a spinalfracture, a medical practitioner obtains access to a target locationincluding at least one vertebra, such as, for example, a fracturedvertebra, in any appropriate manner, such as through incision andretraction of tissue. It is envisioned that the balloon catheter 40 maybe used in any existing surgical method or technique including opensurgery, mini-open surgery, minimally invasive surgery includingpercutaneous surgical implantation, whereby vertebra V is accessedthrough a micro-incision, or sleeve that provides a protected passagewayto the area. Once access to the surgical site(s) are obtained, theparticular surgical procedure is performed for treating the bonedisorder.

Balloon catheter 40 is moved through the incision and positioned so thatballoon 44 is positioned within a vertebral body of the fracturedvertebra. In some embodiments, balloon 44 is moved into the vertebralbody when balloon 44 is in the uninflated configuration. An inflationmaterial, such as, for example, one of the materials discussed above ismoved through passageway 46 such that the material flows throughpassageway 46, out of an opening 56 in distal portion of cylindricalportion 42 and into cavity 48 of balloon 44 to move balloon 44 from theuninflated configuration to the inflated configuration. As the materialflows through passageway 46, flow controller(s) 50 reduce(s) the rate offlow of the material to prevent balloon 44 from being inflated tooquickly. That is, flow controller(s) ensure(s) that balloon 44 isgradually inflated such that balloon 44 pushes cancellous bone of thevertebral body towards cortical walls of the vertebral body to form acavity within the vertebral body. In some embodiments, the cavitycreated by balloon 44 is filled with a material, such as, for example,bone cement. In some embodiments, opening 56 is coaxial with centrallongitudinal axis CLA.

In one embodiment, shown in FIG. 6, balloon catheter 40 comprises one ora plurality of flow controllers 50 coupled to an outer surface 58 ofcylindrical portion 42. In such embodiments, flow controllers 50 may bediscrete bands concentric to central longitudinal axis CLA or discretestrips that extend parallel to central longitudinal axis CLA. In someembodiments, flow controllers 50 are crimped to outer surface 58. Ateach position along cylindrical portion 42 to which flow controllers 50are crimped, the diameter of cylindrical portion 42 decreases. Forexample, cylindrical portion 42 comprises a first portion that is freeof any flow controllers 50 and has an inner diameter d1 and a secondportion that comprises at least one flow controller 50 and has an innerdiameter d2 that is less than inner diameter d1. In some embodiments,cylindrical portion 42 comprises a third portion that comprises at leastone additional flow controller 50 and has an inner diameter d3 that isless than inner diameter d2. In some embodiments, each of flowcontrollers 50 extends 360 degrees about central longitudinal axis CLA,as shown in FIG. 7, for example.

The changes in the inner diameter of cylindrical portion 42 betweeninner diameter d1, inner diameter d2 and inner diameter d3 controls theflow of the inflation material through passageway 46 to graduallyinflate balloon 44. In particular, as the inflation material flowsthrough passageway 46, the changes in the inner diameter of cylindricalportion 42 reduce the rate of flow of the material to prevent balloon 40from being inflated too quickly. That is, the changes in the innerdiameter of cylindrical portion 42 ensure that balloon 44 is graduallyinflated such that balloon 44 pushes cancellous bone of the vertebralbody towards cortical walls of the vertebral body to form a cavitywithin the vertebral body.

In one embodiment, shown in FIG. 8, proximal portion 44 a of balloon 44is coupled to a first section of distal portion 42 b of cylindricalportion 42 and distal portion 44 b of balloon 44 is coupled to a secondsection of distal portion 42 b. Distal portion 42 b comprises one or aplurality of apertures 60 that extend through inner and outer surfaces52, 58 of cylindrical portion 42. Cylindrical portion 42 comprises anend wall 62 that defines a distal limit of passageway 46. Apertures 60are in communication with passageway 46 and cavity 48 of balloon 44 suchthat the inflation material can move out of passageway 46 and intocavity 48 through apertures 60 to inflate balloon 44. In someembodiments, apertures 60 are nonadjacent to one another or spaced apartradially about a circumference of cylindrical portion 42, as shown inFIG. 9. In some embodiments, at least one of apertures 60 may havevarious cross section configurations, such as, for example, circular,oval, oblong, triangular, rectangular, square, polygonal, irregular,uniform, non-unifomi, variable and/or tapered. In some embodiments, atleast one of apertures 60 may be disposed at alternate orientations,relative to central longitudinal axis CLA, such as, for example,transverse, perpendicular and/or other angular orientations such asacute or obtuse, co-axial and/or may be offset or staggered.

As shown in FIG. 8, flow controllers 50 are coupled to outer surface 58of cylindrical portion 42, similar to the embodiment shown in FIG. 6such that the inner diameter of cylindrical portion 42 changes betweeninner diameter d1, inner diameter d2 and inner diameter d3 controls theflow of the inflation material through passageway 46 to graduallyinflate balloon 44. In particular, as the inflation material flowsthrough passageway 46, the changes in the inner diameter of cylindricalportion 42 reduce the rate of flow of the material so when the materialflows through apertures 60 and into cavity 48 of balloon 44, theinflation material does not to inflate balloon 40 too quickly. That is,the changes in the inner diameter of cylindrical portion 42 ensure thatballoon 44 is gradually inflated such that balloon 44 pushes cancellousbone of the vertebral body towards cortical walls of the vertebral bodyto form a cavity within the vertebral body. In such embodiments, flowcontrollers 50 may be discrete bands concentric to central longitudinalaxis CLA.

In some embodiments, proximal portion 42 a of cylindrical portion 42 ofat least one of balloon catheters 40 shown in FIGS. 1, 6 and 8 comprisesan end wall 64 that defines a proximal limit of passageway 46 and a port66 having a lumen 68 that is in communication with passageway 46, asshown in FIG. 10. The inflation material may be injected into passageway46 by positioning an inflation material delivery device, such as, forexample, a syringe adjacent to port 66 and ejecting the inflationmaterial from the delivery device such that the inflation material movesthrough an opening 70 of port 66 and lumen 68 of port 66.

In some embodiments, proximal portion 42 a of cylindrical portion 42 ofat least one of balloon catheters 40 shown in FIGS. 1, 6 and 8 comprisesa threaded portion 72 and an opening 74 that is in communication withpassageway 46, as shown in FIG. 11. Balloon catheter 40 furthercomprises a connector 76 having an inner surface defining a channel 76 ahaving a threaded section 78 and a threaded section 80 that isnonadjacent to or spaced apart from threaded section 78, as shown inFIG. 11. In some embodiments, connector 76 comprises one or a pluralityof flow controllers 50 within channel 76 a. In some embodiments, flowcontrollers 50 are positioned between threaded sections 78, 80. Threadedportion 72 of cylindrical portion 42 is configured to engage threadedsection 78 of connector 76 to couple cylindrical portion 42 to connector76, as shown in FIG. 12, Threaded section 80 of connector 76 isconfigured to engage a threaded section of an inflation materialdelivery device, such as, for example, a syringe 82, as also shown inFIG. 12. In some embodiment, an inflation material is ejected fromsyringe 82 and into channel 76 a of connector 76. Flow controller(s) 50within channel 76 limit(s) the rate of flow of the material throughchannel 76. The material flows from channel 76 a and into passageway 46.In some embodiments, connector 76 can be variously connected withcylindrical portion 42 and/or syringe 82, such as, for example,monolithic, integral connection, frictional engagement, threadedengagement, mutual grooves, screws, adhesive, nails, barbs and/or raisedelement.

In some embodiments, balloon catheter 40 comprises an inner shaft 84positioned within cylindrical portion 42, as shown in FIGS. 13-18, forexample. A distal portion of inner shaft 84 extends through opening 56of cylindrical portion 42 such that at least a portion of the distalportion of inner shaft 84 is positioned outside of passageway 46 ofcylindrical portion 42. Proximal portion 44 a of balloon 44 is coupledto distal portion 42 b of cylindrical portion 42 and distal portion 44 bof balloon 44 is coupled to inner shaft 84. In some embodiments, innershaft 84 comprises an inner surface defining a lumen 86 and one or aplurality of apertures 88 that are in communication with lumen 86 andcavity 48 of balloon 44 such that an inflation material can be movedthrough lumen 86 and apertures 88 and into cavity 48 to inflate balloon44. Inner shaft 84 comprises an end wall 90 that defines a distal limitof lumen 86. In some embodiments, apertures 88 are spaced apart from oneanother radially about a circumference of inner shaft 84, similar toapertures 60 shown in FIG. 9.

One or a plurality of flow controllers 50 are positioned within lumen86. In the embodiments shown in FIGS. 13-18, flow controllers 50 areconfigured to control the flow of the material through lumen 86 as theinflation material travels through lumen 86. In some embodiments, flowcontrollers 50 directly engage an inner surface of inner shaft 84 suchthat a central portion of lumen is unobstructed along centrallongitudinal axis CLA, as shown in FIGS. 13, 14 and 15. In someembodiments, flow controllers 50 directly engage the inner surface ofinner shaft 84 such that at least one of flow controllers 50 blockand/or obstruct the central portion of lumen 86 along centrallongitudinal axis CLA, as shown in FIGS. 13A and 13B.

In some embodiments, balloon catheter 40 comprises one or a plurality offlow controllers 50 within lumen 86 that extend continuously from aproximal portion 84 a of inner shaft 84 to an opposite distal portion 84b of inner shaft 84. That is, one or more of flow controllers 50 withinlumen 86 may have a maximum length along central longitudinal axis CLAthat is equal to a maximum length of inner shaft 84 along centrallongitudinal axis CLA. In some embodiments, balloon catheter 40comprises a single flow controller 50 within lumen 86 that that extendscontinuously from proximal portion 84 a to distal portion 84 b and alsoextends 360 degrees about central longitudinal axis CLA, as shown inFIG. 14, for example. In some embodiments, balloon catheter 40 comprisesa plurality of flow controllers 50 within lumen 86 that each extendcontinuously from proximal portion 84 a to distal portion 84 b and arespaced apart from one another about a circumference of inner shaft 84,as shown in FIG. 15. In some embodiments, the flow controller(s) 50within lumen 86 that extend(s) continuously from proximal portion 84 ato distal portion 84 b has/have a uniform height from proximal portion84 a to distal portion 84 b. In some embodiments, the flow controller(s)50 within lumen 86 that extend(s) continuously from proximal portion 84a to distal portion 84 b taper(s) from proximal portion 84 a to distalportion 84 b. In some embodiments, the flow controller(s) 50 withinlumen 86 that extend(s) continuously from proximal portion 84 a todistal portion 84 b taper(s) from distal portion 84 b to proximalportion 84 a.

In some embodiments, balloon catheter 40 comprises a plurality of flowcontrollers 50 within lumen 86 that are spaced apart from one anotheralong central longitudinal axis CLA, as shown in FIG. 13. In suchembodiments, flow controllers 50 may be discrete bands concentric tocentral longitudinal axis CLA or discrete strips that extend parallel tocentral longitudinal axis CLA. In some embodiments, the spaced apartflow controllers 50 within lumen 86 are uniformly spaced apart from oneanother along central longitudinal axis CLA. In some embodiments, atleast one of the spaced apart flow controllers 50 within lumen 86extends 360 degrees about central longitudinal axis CLA, as shown inFIG. 14, for example. In such embodiments, flow controllers 50 arediscrete bands concentric to central longitudinal axis CLA. In someembodiments, the spaced apart flow controllers 50 within lumen 86 arespaced apart from one another along central longitudinal axis CLA, asshown in FIG. 13 and are also spaced apart from one another about acircumference of inner shaft 84, as shown in FIG. 15. In suchembodiments, flow controllers 50 are discrete strips that extendparallel to central longitudinal axis CLA.

In the embodiments shown in FIGS. 13-17, first surfaces 50 c of thespaced apart flow controllers 50 within lumen 86 engage the innersurface of inner shaft 84.

In some embodiments, the spaced apart flow controllers 50 within lumen86 are each tapered from proximal portion 50 a to distal portion 50 b.In some embodiments, the spaced apart flow controllers 50 within lumen86 are each tapered from distal portion 50 b to proximal portion 50 a.In some embodiments, each of the spaced apart flow controllers 50 withinlumen 86 has the same height, as shown in FIG. 13. In some embodiments,each of the spaced apart flow controllers 50 within lumen 86 has adifferent height, wherein the flow controller 50 having the greatestheight is positioned at proximal portion 84 a of inner shaft 84 and theflow controller 50 having the least height is positioned at distalportion 84 b of inner shaft, as shown in FIG. 16. In some embodiments,each of the spaced apart flow controllers 50 within lumen 86 has adifferent height, wherein the flow controller 50 having the greatestheight is positioned at distal portion 84 b of inner shaft 84 and theflow controller 50 having the least height is positioned at proximalportion 84 a of inner shaft 84, as shown in FIG. 17. The height(s) ofthe flow controller(s) 50 within lumen 86 between the flow controllers50 with the greatest and least heights is less than the height of theflow controller 50 with the greatest height and greater than the flowcontroller 50 with the least height such that flow controllers 50 have astepped configuration, as shown in FIGS. 16 and 17.

In use, to treat a bone disorder, such as, for example, a spinalfracture, a medical practitioner obtains access to a target locationincluding at least one vertebra, such as, for example, a fracturedvertebra, in any appropriate manner, such as through incision andretraction of tissue. Balloon catheter 40 is moved through the incisionand positioned so that balloon 44 is positioned within a vertebral bodyof the fractured vertebra. In some embodiments, balloon 44 is moved intothe vertebral body when balloon 44 is in the uninflated configuration.An inflation material, such as, for example, one of the materialsdiscussed above is moved through lumen 86 such that the material flowsthrough lumen 86, out of apertures 88 and into cavity 48 of balloon 44to move balloon 44 from the uninflated configuration to the inflatedconfiguration. As the material flows through lumen 86, flowcontroller(s) 50 reduce(s) the rate of flow of the material to preventballoon 44 from being inflated too quickly. That is, flow controller(s)50 ensure(s) that balloon 44 is gradually inflated such that balloon 44pushes cancellous bone of the vertebral body towards cortical walls ofthe vertebral body to form a cavity within the vertebral body. In someembodiments, the cavity created by balloon 44 is filled with a material,such as, for example, bone cement. In some embodiments, the inflationmaterial fills passageway 46 before or after the inflation materialmoves balloon 44 from the uninflated configuration to the inflatedconfiguration, as discussed herein. In some embodiments, the inflationmaterial moves out of passageway 46 after the inflation material movesballoon 44 from the uninflated configuration to the inflatedconfiguration to move balloon 44 from the inflated configuration to theuninflated configuration, as discussed herein.

In some embodiments, proximal portion 84 a of inner shaft of at leastone of balloon catheters 40 shown in FIGS. 13-17 comprises an end wall92 that defines a proximal limit of lumen 86 and a port 94 having achannel 96 that is in communication with lumen 86, as shown in FIG. 18.Cylindrical portion 42 comprises port 66 that is in communication withpassageway 46, as also shown in FIG. 18 and described in greater detailwith regard to FIG. 10. In some embodiments, the inflation material maybe injected into lumen 86 by positioning an inflation material deliverydevice, such as, for example, a syringe adjacent to port 94 and ejectingthe inflation material from the delivery device such that the inflationmaterial moves through an opening 98 of port 94 and lumen 96 of port 94.The inflation material will then move through lumen 86 of inner shaft 84in the direction shown by arrow A in FIG. 18 such that the inflationmaterial moves through at least one flow controller 50 positioned withinlumen 86. The inflation material will exit lumen 86 via apertures 88such that the material enters cavity 48 of balloon 44 to move balloon 44from the uninflated configuration to the inflated configuration. In someembodiments, at least a portion of passageway 46 is filled with theinflation material when balloon 44 is in the inflated configuration.

In some embodiments, the inflation material moves out of cavity 48 ofballoon 44 to move balloon 44 from the inflated configuration to theuninflated configuration. This may be done after balloon 44 creates acavity in bone, for example. It is envisioned that removing ballooncatheter 40 from the patient may be easier and/or cause less damage ordamage to the patient when balloon 44 is in the uninflatedconfiguration. In some embodiments, balloon 44 is moved from theinflated configuration to the uninflated configuration by coupling asuction device, such as, for example, a syringe and/or vacuum source toport 66 such that suction is created to move the inflation material outof cavity 48 of balloon 44 and through passageway 46 of cylindricalportion 42 in direction B shown in FIG. 18. The inflation material willcontinue to move in arrow B until the material exits passageway 46through lumen 68 and opening 70 of port 68 of cylindrical portion 42. Insome embodiments, the inflation material will remain within cavity 48 ofballoon 44 until suction is applied. That is, balloon 44 will remain inthe inflated configuration until suction is applied at port 66 to drawthe inflation material through passageway 46 of cylindrical portion 42.

In some embodiments, balloon catheter 40 comprises inner shaft 84 and isconfigured such that the inflation material moves through passageway 46of cylindrical portion 42 in a space between inner shaft 84 andcylindrical portion 42 to move balloon 44 between the uninflated andinflated configurations, as discussed herein, Flow controllers 50 arepositioned within passageway 46, between the outer surface of innershaft 84 and inner surface 52 of cylindrical portion 42, as shown inFIGS. 19-30, in order to limit the flow rate of the inflation materialas it flows through passageway 46.

In one embodiment, shown in FIGS. 19-20B, balloon catheter 40 comprisesone or a plurality of flow controllers 50 that extend continuously fromthe outer surface of inner shaft 84 to inner surface 52 of cylindricalportion 42. As shown in FIG. 19, flow controllers 50 are spaced apartfrom one another along central longitudinal axis CLA. However it isenvisioned that balloon catheter 40 may comprise a single flowcontroller 50 that extends continuously from proximal portion 42 a ofcylindrical portion 42 to distal portion 42 b of cylindrical portion 42and/or from proximal portion 84 a of inner shaft 84 to distal portion 84b of inner shaft 84 such that the single flow controller extends theentire length of at least one of cylindrical portion 42 and inner shaft84.

In the embodiment shown in FIG. 20A, flow controller(s) 50 comprise(s) aplate having one or a plurality of discrete conduits 100 that eachextend continuously through and between opposite proximal and distalsurfaces 50 a, 50 b of flow controller(s) 50. In embodiments thatcomprise a plurality of conduits 100, conduits 100 are nonadjacent toone another or spaced apart such that one conduit 100 is not incommunication with another one of conduits 100. In some embodiments,conduits 100 are positioned radially about a circumference ofcylindrical portion 42, as shown in FIG. 20A In some embodiments,conduits 100 may have various cross section configurations, such as, forexample, oval, oblong, triangular, rectangular, square, polygonal,irregular, uniform, non-uniform, variable, tubular and/or tapered.

In the embodiment shown in FIG. 20B, flow controller(s) comprise(s) afoam material, such as, for example, an open cell foam material orspongiform material/structure comprising a plurality of pores 54, asdiscussed above with regard to the embodiment shown in FIG. 1B. In someembodiments, at least one of pores 54 extends through proximal anddistal surfaces 50 a, 50 b a respective flow controller 50. In someembodiments, at least one of pores 54 extends through one of proximaland distal surfaces 50 a, 50 b without extending through the other oneof proximal and distal surfaces 50 a, 50 b. In some embodiments, atleast one of pores 54 is in communication with at least another one ofpores 54. In some embodiments, pores 54 are interconnected with oneanother. In some embodiments, pores 54 are nonadjacent to one another,spaced apart and/or are not in communication with one another.

In some embodiments, balloon catheter 40 comprises one or a plurality offlow controllers 50 that are coupled to the outer surface of inner shaft84, as shown in FIG. 21, for example. In such embodiments, flowcontrollers 50 may be discrete bands concentric to central longitudinalaxis CLA or discrete strips that extend parallel to central longitudinalaxis CLA. In some embodiments, flow controller(s) coupled to the outersurface of inner shaft 84 extend continuously from a proximal portion 84a of inner shaft 84 to an opposite distal portion 84 b of inner shaft84. That is, one or more of flow controllers 50 coupled to the outersurface inner shaft 84 may have a maximum length along centrallongitudinal axis CLA that is equal to a maximum length of inner shaft84 along central longitudinal axis CLA. In some embodiments, ballooncatheter 40 comprises a single flow controller 50 coupled to the outersurface of inner shaft 84 that extends continuously from proximalportion 84 a to distal portion 84 b and also extends 360 degrees aboutcentral longitudinal axis CLA, as shown in FIG. 22, for example. In suchembodiments, flow controllers 50 are discrete bands concentric tocentral longitudinal axis CLA. In some embodiments, balloon catheter 40comprises a plurality of flow controllers 50 coupled to the outersurface of inner shaft 84 that extend continuously from proximal portion84 a to distal portion 84 b and are spaced apart from one another abouta circumference of inner shaft 84, as shown in FIG. 23. In suchembodiments, flow controllers 50 are discrete strips that extendparallel to central longitudinal axis CLA. In some embodiments, the flowcontroller(s) 50 coupled to the outer surface of inner shaft 84 thatextend(s) continuously from proximal portion 84 a to distal portion 84 bhas/have a uniform height from proximal portion 84 a to distal portion84 b. In some embodiments, the flow controller(s) 50 coupled to theouter surface of inner shaft 84 that extend(s) continuously fromproximal portion 84 a to distal portion 84 b taper(s) from proximalportion 84 a to distal portion 84 b. In some embodiments, the flowcontroller(s) 50 coupled to the outer surface of inner shaft 84 thatextend(s) continuously from proximal portion 84 a to distal portion 84 btaper(s) from distal portion 84 b to proximal portion 84 a.

In some embodiments, balloon catheter 40 comprises a plurality of flowcontrollers 50 coupled to the outer surface of inner shaft 84 that arespaced apart from one another along central longitudinal axis CLA, asshown in FIG. 21. In some embodiments, the spaced apart flow controllers50 coupled to the outer surface of inner shaft 84 are uniformly spacedapart from one another along central longitudinal axis CLA. In someembodiments, at least one of the spaced apart flow controllers 50coupled to the outer surface of inner shaft 84 extends 360 degrees aboutcentral longitudinal axis CLA, as shown in FIG. 22, for example. In someembodiments, the spaced apart flow controllers 50 coupled to the outersurface of inner shaft 84 are spaced apart from one another alongcentral longitudinal axis CLA, as shown in FIG. 21 and are also spacedapart from one another about a circumference of inner shaft 84, as shownin FIG. 23.

In some embodiments, the spaced apart flow controllers 50 coupled to theouter surface of inner shaft 84 are each tapered from proximal portion50 a to distal portion 50 b. In some embodiments, the spaced apart flowcontrollers 50 coupled to the outer surface of inner shaft 84 are eachtapered from distal portion 50 b to proximal portion 50 a. In someembodiments, each of the spaced apart flow controllers 50 coupled to theouter surface of inner shaft 84 have the same height, as shown in FIG.21. In some embodiments, each of the spaced apart flow controllers 50coupled to the outer surface of inner shaft 84 have a different height,wherein the flow controller 50 having the greatest height is positionedat proximal portion 84 a of inner shaft 84 and the flow controller 50having the least height is positioned at distal portion 84 b of innershaft, as shown in FIG. 24. In some embodiments, each of the spacedapart flow controllers coupled to the outer surface of inner shaft 84have a different height, wherein the flow controller 50 having thegreatest height is positioned at distal portion 84 b of inner shaft 84and the flow controller 50 having the least height is positioned atproximal portion 84 a of inner shaft 84, as shown in FIG. 25. Theheight(s) of the flow controller(s) 50 coupled to the outer surface ofinner shaft 84 between the flow controllers 50 with the greatest andleast heights is less than the height of the flow controller 50 with thegreatest height and greater than the flow controller 50 with the leastheight such that flow controllers 50 have a stepped configuration, asshown in FIGS. 24 and 25.

In some embodiments, balloon catheter 40 comprises one or a plurality offlow controllers 50 positioned in passageway 46 of cylindrical portion42 between inner shaft 84 and inner surface 52 of cylindrical portion 42that are coupled to inner surface 52 of cylindrical portion 42 andextend continuously from a proximal portion 42 a of cylindrical portion42 to an opposite distal portion 42 b of cylindrical portion 42. Thatis, one or more of flow controllers 50 coupled to inner surface 52 ofcylindrical portion 42 may have a maximum length along centrallongitudinal axis CLA that is equal to a maximum length of cylindricalportion 42 along central longitudinal axis CLA. In some embodiments,balloon catheter 40 comprises a single flow controller 50 coupled toinner surface 52 of cylindrical portion 42 that extends continuouslyfrom proximal portion 42 a to distal portion 42 b and also extends 360degrees about central longitudinal axis CLA, as shown in FIG. 27, forexample. In some embodiments, balloon catheter 40 comprises a pluralityof flow controllers 50 coupled to inner surface 52 of cylindricalportion 42 that extend continuously from proximal portion 42 a to distalportion 42 b and are spaced apart from one another about a circumferenceof cylindrical portion 42, as shown in FIG. 28. In some embodiments, theflow controller(s) 50 coupled to inner surface 52 of cylindrical portion42 that extend(s) continuously from proximal portion 42 a to distalportion 42 b has/have a uniform height from proximal portion 42 a todistal portion 42 b. In some embodiments, the flow controller(s) 50coupled to inner surface 52 of cylindrical portion 42 that extend(s)continuously from proximal portion 42 a to distal portion 42 b taper(s)from proximal portion 42 a to distal portion 42 b. In some embodiments,the flow controller(s) 50 coupled to inner surface 52 of cylindricalportion 42 extend(s) continuously from proximal portion 42 a to distalportion 42 b taper(s) from distal portion 42 b to proximal portion 42 a.

In some embodiments, balloon catheter 40 comprises a plurality of flowcontrollers 50 coupled to inner surface 52 of cylindrical portion 42that are spaced apart from one another along central longitudinal axisCLA, as shown in FIG. 26. In such embodiments, flow controllers 50 maybe discrete bands concentric to central longitudinal axis CLA ordiscrete strips that extend parallel to central longitudinal axis CLA.In some embodiments, the spaced apart flow controllers 50 coupled toinner surface 52 of cylindrical portion 42 are uniformly spaced apartfrom one another along central longitudinal axis CLA. In someembodiments, at least one of the spaced apart flow controllers 50coupled to inner surface 52 of cylindrical portion 42 extends 360degrees about central longitudinal axis CLA, as shown in FIG. 27, forexample. In such embodiments, flow controllers 50 are discrete bandsconcentric to central longitudinal axis CLA. In some embodiments, thespaced apart flow controllers 50 coupled to inner surface 52 ofcylindrical portion 42 are spaced apart from one another along centrallongitudinal axis CLA, as shown in FIG. 26 and are also spaced apartfrom one another about a circumference of inner shaft 84, as shown inFIG. 28. In such embodiments, flow controllers 50 are discrete stripsthat extend parallel to central longitudinal axis CLA.

In some embodiments, the spaced apart flow controllers 50 coupled toinner surface 52 of cylindrical portion 42 are each tapered fromproximal portion 50 a to distal portion 50 b. In some embodiments, thespaced apart flow controllers 50 coupled to inner surface 52 ofcylindrical portion 42 are each tapered from distal portion 50 b toproximal portion 50 a. In some embodiments, each of the spaced apartflow controllers 50 coupled to inner surface 52 of cylindrical portion42 have the same height, as shown in FIG. 26. In some embodiments, eachof the spaced apart flow controllers 50 coupled to inner surface 52 ofcylindrical portion 42 have a different height, wherein the flowcontroller 50 having the greatest height is positioned at proximalportion 42 a of cylindrical portion 42 and the flow controller 50 havingthe least height is positioned at distal portion 42 b of cylindricalportion 42, as shown in FIG. 29. In some embodiments, each of the spacedapart flow controllers 50 inner surface 52 of cylindrical portion 42have a different height, wherein the flow controller 50 having thegreatest height is positioned at distal portion 42 b of cylindricalportion 42 and the flow controller 50 having the least height ispositioned at proximal portion 42 a of cylindrical portion 42, as shownin FIG. 30. The height(s) of the flow controller(s) 50 coupled to innersurface 52 of cylindrical portion 42 between the flow controllers 50with the greatest and least heights is less than the height of the flowcontroller 50 with the greatest height and greater than the flowcontroller 50 with the least height such that flow controllers 50 have astepped configuration, as shown in FIGS. 29 and 30.

In use, to treat a bone disorder, such as, for example, a spinalfracture, a medical practitioner obtains access to a target locationincluding at least one vertebra, such as, for example, a fracturedvertebra, in any appropriate manner, such as through incision andretraction of tissue. Balloon catheter 40 is moved through the incisionand positioned so that balloon 44 is positioned within a vertebral bodyof the fractured vertebra. In some embodiments, balloon 44 is moved intothe vertebral body when balloon 44 is in the uninflated configuration.An inflation material, such as, for example, one of the materialsdiscussed above is moved through passageway 46 and opening 56 such thatthe material moves into cavity 48 of balloon 44 to move balloon 44 fromthe uninflated configuration to the inflated configuration. As thematerial flows through passageway 46, flow controller(s) 50 reduce(s)the rate of flow of the material to prevent balloon 44 from beinginflated too quickly. That is, flow controller(s) 50 ensure(s) thatballoon 44 is gradually inflated such that balloon 44 pushes cancellousbone of the vertebral body towards cortical walls of the vertebral bodyto form a cavity within the vertebral body. In some embodiments, thecavity created by balloon 44 is filled with a material, such as, forexample, bone cement. In some embodiments, at least a portion ofpassageway 46 is filled with the inflation material when balloon 44 isin the inflated configuration.

In one embodiment, shown in FIGS. 31 and 32, balloon catheter 40comprises inner shaft 84 and one or a plurality of flow controllers 50coupled to outer surface 58 of cylindrical portion 42. In suchembodiments, flow controllers 50 are discrete bands concentric tocentral longitudinal axis CLA. In some embodiments, flow controllers 50are crimped to outer surface 58. At each position along cylindricalportion 42 to which flow controllers 50 are crimped, the diameter ofcylindrical portion 42 decreases. For example, cylindrical portion 42comprises a first portion that is free of any flow controllers 50 andhas an inner diameter d1 and a second portion that comprises at leastone flow controller 50 and has an inner diameter d2 that is less thaninner diameter d1. In some embodiments, cylindrical portion 42 comprisesa third portion that comprises at least one additional flow controller50 and has an inner diameter d3 that is less than inner diameter d2. Insome embodiments, cylindrical portion 42 comprises a fourth portion thatcomprises at least one additional flow controller 50 and has an innerdiameter d4 that is less than inner diameter d3. In some embodiments,each of flow controllers 50 extends 360 degrees about centrallongitudinal axis CLA, as shown in FIG. 32, for example.

The changes in the inner diameter of cylindrical portion 42 betweeninner diameter d1, inner diameter d2, inner diameter d3 and innerdiameter d4 controls the flow of the inflation material throughpassageway 46 to gradually inflate balloon 44. In particular, as theinflation material flows through passageway 46, the changes in the innerdiameter of cylindrical portion 42 reduce the rate of flow of thematerial to prevent balloon 40 from being inflated too quickly. That is,the changes in the inner diameter of cylindrical portion 42 ensure thatballoon 44 is gradually inflated such that balloon 44 pushes cancellousbone of the vertebral body towards cortical walls of the vertebral bodyto form a cavity within the vertebral body.

In some embodiments, proximal portion 42 a of cylindrical portion 42 ofat least one of balloon catheters 40 shown in FIGS. 19-32 comprises endwall 64 that defines a proximal limit of passageway 46 and port 66, asdescribed in greater detail with the discussion of the embodiment shownin FIG. 10. As shown in FIG. 33, inner shaft 84 extends through end wall46. The inflation material may be injected into passageway 46 bypositioning an inflation material delivery device, such as, for example,a syringe adjacent to port 66 and ejecting the inflation material fromthe delivery device such that the inflation material moves throughopening 70 of port 66 and lumen 68 of port 66.

In some embodiments, at least one of balloon catheters 40 shown in FIGS.19-32 comprises a connector 102 that is positioned about proximalportions 42 a, 84 a of cylindrical portion 42 and inner shaft 84, asshown in FIG. 34. Connector 102 comprises a port 104 having a lumen 106that is in communication with passageway 46, as shown in FIG. 34. Theinflation material may be injected into passageway 46 by positioning aninflation material delivery device, such as, for example, a syringeadjacent to port 104 and ejecting the inflation material from thedelivery device such that the inflation material moves through anopening 108 of port 104 and lumen 106 of port 104. In some embodiments,balloon catheter 40 comprises at least one or a plurality of flowcontrollers 50 positioned within passageway 46 adjacent to port 104, asshown in FIG. 34. In some embodiments, flow controllers 50 arepositioned distal to port 104 such that as an inflation material isejected from a delivery device and into passageway 46 through port 104,flow controller(s) 50 will limit the rate of flow of the materialthrough passageway 46. In some embodiments, at least one of flowcontrollers 50 adjacent to port 104 extends 360 degrees about centrallongitudinal axis CLA, as shown in FIG. 35, for example. In suchembodiments, flow controllers 50 are discrete strips that are concentricwith central longitudinal axis CLA. In some embodiments, flowcontrollers 50 adjacent to port 104 are spaced apart from one anotherabout a circumference of cylindrical portion 42, as shown in FIG. 36. Insuch embodiments, flow controllers 50 are discrete strips that extendparallel to central longitudinal axis CLA.

In some embodiments, a kit containing one or more components of ballooncatheter 40 is provided. The kit may comprise components from any of theembodiments discussed herein. In some embodiments, the kit comprises oneor more of the inflation materials discussed herein. The kit may alsocomprise one or more component to assist with inserting balloon catheter40 into a patient, such as, for example, one or a plurality of cannulas.In some embodiments, the kit comprises a plurality of cannulas havingdifferent lengths configured for use with different size patients.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. An inflatable bone tamp comprising: a first shaftextending along a central longitudinal axis between a first proximalportion and an opposite first distal portion, the first shaft includingan inner surface and an outer surface, the inner surface defining alumen extending therethrough, and the first distal portion including atleast one aperture therethrough; a second shaft extending between asecond proximal portion and an opposite second distal portion, thesecond shaft including an inner surface, the first shaft being receivedinside the second shaft, and the outer surface of the first shaft andthe inner surface of the second shaft defining a passageway extendingthrough the second shaft; an inflatable balloon having an interior, adistal end coupled to the first distal portion of the first shaft and aproximal end coupled to the second distal portion of the second shaftsuch that a material can flow through the second shaft and into theballoon to inflate the balloon; and a plurality of flow controllerscoupled to one of the outer surface of the first shaft and the innersurface of the second shaft inside the passageway that controls the flowof the material through the passageway and into the balloon, each of theplurality of flow controllers protruding into the passageway and beingspaced apart from one another about a circumference of a correspondingone of the outer surface of the first shaft and the inner surface of thesecond shaft, a first of the plurality of flow controllers positioned ata first circumferential position, a second of the plurality of flowcontrollers positioned at a second circumferential position, a third ofthe plurality of flow controllers positioned at a third circumferentialposition, and a fourth of the plurality of flow controllers positionedat a fourth circumferential position, the first circumferential positionbeing adjacent the second circumferential position, the secondcircumferential position being adjacent the third circumferentialposition, the third circumferential position being adjacent the fourthcircumferential position, and the fourth circumferential position beingadjacent the first circumferential position, the first circumferentialposition being opposite from the third circumferential position, and thesecond circumferential position being opposite from the fourthcircumferential position, each of the plurality of flow controllersincluding at least a first lateral surface, a second lateral surface,and an inward-facing surface extending between the first lateral surfaceand the second lateral surface; wherein the passageway between the firstshaft and the second shaft fluidly communicates with the interior of theballoon, and the interior of the balloon fluidly communicates with thelumen of the first shaft through the at least one aperture; and whereinmaterial injected into the passageway moves through the passageway,between the inward-facing surfaces of the plurality of flow controllersand a corresponding opposite one of the outer surface of the first shaftand the inner surface of the second shaft, and between the first lateralsurfaces and the second lateral surfaces of adjacent ones of theplurality of flow controllers, and fills the interior of the balloon tofacilitate inflation thereof, and the material exits the interior of theballoon through the at least one aperture, and moves through the lumento facilitate deflation of the balloon.
 2. The inflatable bone tamp ofclaim 1, wherein the first lateral surfaces, the second lateralsurfaces, and the inward-facing surfaces of each of the first, thesecond, the third, and the fourth of the plurality of flow controllersat least in part reside in corresponding planes that are parallel to thecentral longitudinal axis.
 3. The inflatable bone tamp of claim 1,wherein the inward-facing surfaces of the first, the second, the third,and the fourth of the plurality of flow controllers are concave.
 4. Theinflatable bone tamp of claim 1, further comprising another plurality offlow controllers spaced axially apart from the plurality of flowcontrollers relative to the central longitudinal axis, each of theanother plurality of flow controllers protruding into the passageway andbeing spaced apart from one another about a circumference of one of theouter surface of the first shaft and the inner surface of the secondshaft.
 5. The inflatable bone tamp of claim 4, wherein a first of theanother plurality of flow controllers positioned at a firstcircumferential position, a second of the another plurality of flowcontrollers positioned at a second circumferential position, a third ofthe another plurality of flow controllers positioned at a thirdcircumferential position, and a fourth of the another plurality of flowcontrollers positioned at a fourth circumferential position, each of theanother plurality of flow controllers including at least a first lateralsurface, a second lateral surface, and an inward-facing surfaceextending between the first lateral surface and the second lateralsurface.
 6. The inflatable bone tamp of claim 1, wherein each of theplurality of flow controllers is comprised of discrete strips coupledalong the one of the outer surface of the first shaft and the innersurface of the second shaft parallel to the central longitudinal axis.7. The inflatable bone tamp of claim 1, wherein the lumen is taperedfrom the first proximal portion to a midpoint of the lumen and from themidpoint of the lumen to the first distal portion.
 8. The inflatablebone tamp of claim 1, further comprising an end portion connected to thefirst proximal portion of the first shaft and connected to the secondproximal portion of the second shaft, the end portion including a firstport communicating with the passageway and a second port communicatingwith the lumen.
 9. The inflatable bone tamp of claim 1, wherein the bonetamp includes a proximal end and an opposite distal end, the balloonbeing positioned at and adjacent the distal end of the bone tamp, andthe plurality of flow controllers being positioned adjacent the proximalend of the bone tamp.
 10. The inflatable bone tamp of claim 9, whereinanother plurality of flow controllers is positioned adjacent the distalend of the bone tamp.
 11. An inflatable bone tamp comprising: an outershaft extending along a central longitudinal axis between oppositeproximal end and distal end portions, the outer shaft including an innersurface; an inner shaft positioned within the outer shaft and extendingbetween opposite proximal end and distal end portions, the inner shafthaving an inner surface and an outer surface, and the distal end portionof the inner shaft comprising apertures; a passageway formed between theouter surface of the inner shaft and the inner surface of the outershaft, and a lumen formed by the inner surface of the inner shaft; aballoon having a distal end coupled to the distal end portion of theinner shaft and a proximal end coupled to the distal end portion of theouter shaft, the balloon having an interior communicating with thepassageway and the lumen, the interior of the balloon communicating withthe lumen via the apertures in the distal end portion of the innershaft; and a plurality of flow controllers coupled to one of the outersurface of the inner shaft and the inner surface of the outer shaftwithin the passageway, each of the plurality of flow controllers beingspaced apart from one another about a circumference of a correspondingone of the outer surface of the inner shaft and the inner surface of theouter shaft, and each of the plurality of flow controllers protrudinginto the passageway and including an exposed first side surface, anexposed second side surface, and an exposed inward-facing surface;wherein a material injected into the passageway moves through thepassageway, between the inward-facing surfaces of the plurality of flowcontrollers and a corresponding opposite one of the outer surface of theinner shaft and the inner surface of the outer shaft, between theexposed first side surfaces and the exposed second side surfaces ofadjacent ones of the plurality of flow controllers, and into theinterior of the balloon to inflate the balloon; and wherein the materialmoves out of the balloon, through the apertures, and into the lumen andout of the inner shaft to deflate the balloon.
 12. The inflatable bonetamp of claim 11, wherein the bone tamp includes a proximal end and anopposite distal end, the balloon being positioned at and adjacent thedistal end of the bone tamp, and the plurality of flow controllers beingpositioned at least adjacent the proximal end of the bone tamp.
 13. Theinflatable bone tamp of claim 11, further comprising a first of theplurality of flow controllers positioned at a first circumferentialposition, a second of the plurality of flow controllers positioned at asecond circumferential position, a third of the plurality of flowcontrollers positioned at a third circumferential position, and a fourthof the plurality of flow controllers positioned at a fourthcircumferential position, the first circumferential position beingadjacent the second circumferential position, the second circumferentialposition being adjacent the third circumferential position, the thirdcircumferential position being adjacent the fourth circumferentialposition, and the fourth circumferential position being adjacent thefirst circumferential position, the first circumferential position beingopposite from the third circumferential position, and the secondcircumferential position being opposite from the fourth circumferentialposition.
 14. An inflatable bone tamp comprising: an outer shaftextending along a central longitudinal axis between opposite proximalend and distal end portions, the outer shaft including an inner surface;an inner shaft positioned within the outer shaft and extending betweenopposite proximal end and distal end portions, the inner shaft having aninner surface and an outer surface, and the distal end portion of theinner shaft comprising apertures; a passageway formed between the outersurface of the inner shaft and the inner surface of the outer shaft, anda lumen formed by the inner surface of the inner shaft; a proximalportion coupled to the shafts such that a first port of the proximalportion is in communication with the passageway and a second port of theproximal portion is in communication with the lumen; a balloon having adistal end coupled to the distal end portion of the inner shaft and aproximal end coupled to the distal end portion of the outer shaft, theballoon having an interior communicating with the passageway and thelumen, the interior of the balloon communicating with the lumen via theapertures in the distal end portion of the inner shaft; and a pluralityof flow controllers coupled to one of the outer surface of the innershaft and the inner surface of the outer shaft within the passageway,each of the plurality of flow controllers being spaced apart from oneanother about a circumference of a corresponding one of the outersurface of the inner shaft and the inner surface of the outer shaft, andeach of the plurality of flow controllers protruding into the passagewayand including an exposed first side surface, an exposed second sidesurface, and an exposed inward-facing surface; wherein a materialinjected into the first port moves through the passageway, between theinward-facing surfaces of the plurality of flow controllers and acorresponding opposite one of the outer surface of the inner shaft andthe inner surface of the outer shaft, between the exposed first sidesurfaces and the exposed second side surfaces of adjacent ones of theplurality of flow controllers, and into the interior of the balloon toinflate the balloon; and wherein the material moves out of the balloon,through the apertures, and into the lumen and out of the second port todeflate the balloon upon suction being applied to the second port. 15.The inflatable bone tamp of claim 14, wherein the bone tamp includes aproximal end and an opposite distal end, the proximal portion beingpositioned at and adjacent the proximal end of the bone tamp, theballoon being positioned at and adjacent the distal end of the bonetamp, and the plurality of the flow controllers being positioned atleast adjacent the proximal portion.
 16. The inflatable bone tamp ofclaim 14, further comprising a first of the plurality of flowcontrollers positioned at a first circumferential position, a second ofthe plurality of flow controllers positioned at a second circumferentialposition, a third of the plurality of flow controllers positioned at athird circumferential position, and a fourth of the plurality of flowcontrollers positioned at a fourth circumferential position, the firstcircumferential position being adjacent the second circumferentialposition, the second circumferential position being adjacent the thirdcircumferential position, the third circumferential position beingadjacent the fourth circumferential position, and the fourthcircumferential position being adjacent the first circumferentialposition, the first circumferential position being opposite from thethird circumferential position, and the second circumferential positionbeing opposite from the fourth circumferential position.